Health TrialsbyHealthPanel

A Study of Time-Restricted Eating in Childhood Cancer Survivors

ConditionChildhood Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This study will look at whether motivational sessions (including regular calls with a trained health coach) in combination with time-restricted eating (TRE) is an effective way to achieve weight loss and lower cardiometabolic risk in adult survivors of childhood cancer. The researchers will look at how effective this intervention is compared to the usual approach, which is to review educational materials and measure weight once a month. This study will not provide treatment for any disease or cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Enrolled in the Childhood Cancer Survivor Study (a cohort of 5+ year survivors of childhood cancer diagnosed at age < 21 between 1970-1999 at 31 participating institutions in North America)

Are ≥18 years old

Self-reported body mass index ≥ 25 kg/m2

Are not pregnant or do not intend to become pregnant in the next year

Disqualifiers

Do not reside in the United States

Do not speak English

Eating window < 12 hours per 24-hour day

On insulin or GLP-1 agonist

Trial design

Design model

Parallel

Treatments tested in this trial

  • Children's Oncology Group Heart Health Link

    Other intervention

    Educational materials on healthy lifestyle behaviors.

  • Monthly weights

    Other intervention

    Weight (kg): measured remotely via Withings Body + scale, Height, weight, waist circumference, BP, and % body fat

  • Fasting

    Other intervention

    (14-hour fast x 2 weeks; 15-hour fast x- 1 week; 16-hour fast for the remainder of the active intervention)

  • Calls

    Other intervention

    Month 1-3: Bi-weekly call using motivational interviewing Months 4-6: Monthly call using motivational interviewing Support via SMS text

  • Participant Questionnaires

    Other intervention

    Questions on worry, perceived self-efficacy, health beliefs and knowledge of late effects (adapted from EQUAL study), Behavioral Risk Factor Surveillance System, Physical Activity Questionnaire, Link to Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool with accompanying sleep module

  • Dried blood spot

    Other intervention

    Glucose, insulin, hemoglobin A1c, lipids. Measured remotely in the fasting state via dried blood spots in the participant's home.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 5 interventions
Group B: Control GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Percent change in weight

Time frame
at 12 months

Secondary outcomes

1

Change in glucose

via dried blood spots

Time frame
up to 12 months
2

Change in insulin

via dried blood spots

Time frame
up to 12 months
3

Change in HbA1c

via dried blood spots

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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